Drug Eluting Stents: an update Abbott Vascular. All rights reserved.

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1 Drug Eluting Stents: an update

2 DES: Science and Education for Better Practice--Introduction The clinical benefits of DES in reducing the risk of restenosis are well established. Recently the safety profile of DES has become the focus of growing attention following presentation of data indicating an increased risk of late stent thrombosis (LST) with the sirolimus (SES) and paclitaxel-eluting stents (PES) compared with BMS. These findings have raised concerns over the use of DES. 2

3 Efficacy: Randomized trials and real world registries 3

4 DES reduce restenosis and TLR rates Source: Babapulle et al. Lancet 2004; 364:

5 DES reduce reintervention rate Analysis of 14 Trials Comparing Sirolimus Eluting Stents with Bare-Metal Stents 4958 patients, follow-up: months Hazard Ratios for Death, Myocardial Infarction, or Reintervention Source: N Engl J Med 2007;356: Kaplan Meier Curves for Survival Free of Myocardial Infarction and Reintervention

6 Efficacy of DES Reduction of TLR Taxus I Taxus II Taxus IV Taxus V Taxus VI 6 Source: Stone et al. N Engl J Med 2007;356:

7 DES do not reduce mortality rate 7 Source: Babapulle et al. Lancet 2004; 364:

8 No reduction in Death or MI rate Analysis of 14 Trials Comparing Sirolimus Eluting Stents with Bare-Metal Stents 4958 patients, follow-up: months Hazard Ratios for Individual Trials and for the Pooled Population Source: N Engl J Med 2007;356: Similar result for combined endpoint of death or any MI: OR 0.97 ( ) 8

9 Safety: Late and very late stent thrombosis 9

10 Stent thrombosis (%) History of Stent Thrombosis % Coumadin High-pressure balloons and Ticlid % 1.4% 0.8% 0.6% 0 PS STRESS Colombo ISAR STARS Schatz et al. Circulation.1991;83:148; 2. Fischman et al. N Engl J Med. 1994;331496; 3. Colombo et al. Circulation.1995;91:1676; 4. Schömig et al.circulation.1994,90:2716; 5. Leon et al. N Engl J Med. 1998;339:1665; 6. Joner et al. J Am Coll Cardiol. 2006;48:193. Ticlid is a trademark of the Sanofi-Aventis corporation. 10

11 Patients (%) Stent Thrombosis in the non-des era 3.0 ± 1.2% up to 30 days in ± 20,000 patients Study No.Pts Years Karillon De Servi Schuhlen Cutlip Moussa Werner Cheneau* ARTS *IVUS-Guided 1 Multi-vessel stenting Source: Kereiakes et al, Rev Cardiovasc Med

12 Stent Thrombosis is a Rare Serious Adverse Event that Usually Occurs Early Post-BMS Implantation Very Late ST? > 6 months Late ST 1 to 6 months Sub Acute ST 24 hours to 30 days Acute ST 24 hours ST = Stent Thrombosis 12

13 13

14 Late Stent Thrombosis in RCTs with 1 year Follow-up Overall ST Late ST (>1 mo<1 year) DES BMS DES BMS Study RAVEL 0/120 0/118 0/120 0/118 SIRIUS 2/533 4/525 1/533 3/525 E-SIRIUS 2/175 0/177 0/175 0/177 C-SIRIUS 1/50 1/50 0/50 1/50 ASPECT 0/90 0/48 0/90 0/48 ELUTES 1/153 1/39 0/153 0/39 TAXUS I 0/31 0/30 0/31 0/30 TAXUSII 3/266 0/270 2/266 0/270 TAXUSIV 4/662 5/652 2/662 1/652 DELIVER 2/522 2/519 1/522 1/519 TOTAL 0.58% 0.53% 0.23% 0.25% P= 0.9 P= Source: Moreno R et al. JACC 2005;45;954-9

15 Stent Thrombosis: Sirolimus vs Paclitaxel in the Long Term Similar Rate in Late Stent Thrombosis for Cypher R and Taxus R vs. BMS TAXUS II (3 yr), IV (3 yr), V (1 yr), VI (2 yr) RAVEL, SIRIUS, E-SIRIUS and C-SIRIUS % % % 98 P = % 98 P = % 97 After 9 months : 8 vs After 12 months : 4 vs Bare Metal Stent TAXUS R 96 Bare Metal Stent CYPHER R Time after initial procedure (months) Time after initial procedure (months) Statistically Non Significant at AHA

16 Stent Thrombosis (%) Incidence of Late DES Stent Thrombosis in Observational Non Randomized Studies Total ST Late ST Follow-up Ong. N=2, Months Iakovou N=2,229 9Months Rodriguez* N= Months 16 Kuchulakanti N=2,974 6 Months Park N= Months Urban N=13, Months * ERACI II Study

17 The Convenient Truth from Randomized Contolled Trials, Meta-analyses, and Industry Driven Registries VERY REASSURING But 17

18 Definitions of Stent Thrombosis in Randomized Clinical Trials usually are Conservative Late Thrombosis > 30 days Myocardial infarction attributable to the target vessel WITH Angiographic documentation (site reported or by QCA) Thrombus or total occlusion at the target site AND > 30 days after the index procedure in the absence of a intervening revascularization of the target vessel 18

19 Definitions of Stent Thrombosis in Randomized Clinical Trials usually are Conservative Why «Late thrombosis» rates can be underestimated in real life i.e. out of Clinical Trials? 1. Sudden death related to acute stent thrombosis usually does not appear in statistics 2. Several non fatal MI patients related to stent thrombosis do not undergo repeated angio 3. Several angiographic in stent restenoses are quoted «restenosis» but could be/are thrombotic (non proliferative) restenosis 4. Several stent thromboses are asymptomatic (post-mi) 19

20 Stent thrombosis: ARC definition 20 Source: Circulation. 2007;115:

21 The Recent Inconvenient Truth from Registries, Real Life Data and Long Term Follow-up 21

22 Stent Thrombosis is a Rare Serious Adverse Event that Can Occur Any Time Post-DES Implantation Very Late ST? > 6 months Late ST 1 to 6 months Sub Acute ST 24 hours to 30 days Acute ST 24 hours ST = Stent Thrombosis 22

23 Late Stent Thrombosis Late thrombosis in drug-eluting coronary stents after Discontinuation of antiplatelet therapy because surgical procedures CYPHER TAXUS DAYS BETWEEN ANTIPLATELET DISCONTINUATION AND EVENT 730 Days after PCI Source: McFadden EP et al. Lancet 2004;364:

24 Stent Thrombosis (%) Mortality Related to Late Stent Thrombosis of Drug-Eluting Stents is High Total ST Late ST Ong. N=2,006 Iakovou N=2,229 Rodriguez N=225 Kuchulakanti N=2,974 Park N=594 EVASTENT N=1731 DEATH RATE % 45 % 43 % 29 % 40 % 46 %

25 Late clinical events after Clopidogrel discontinuation may limit the benefit of Drug-Eluting Stents An Observational Study of DES versus BMS Basket-Late study For every 100 patients treated with a drug-eluting stent, 3.3 cases of cardiac death or MI are induced for a reduction of 5 cases of target lesion revascularization 25 Source: Pfisterer ME, ACC 2006

26 Late clinical events after Clopidogrel discontinuation may limit the benefit of Drug-Eluting Stents An Observational Study of DES versus BMS Basket-Late study Source: Pfisterer et al. J Am Coll Cardio 2006;48:

27 27 Source: Stone GW et al, N Engl J Med 2007

28 Paclitaxel Eluting Stents 28 Source: Stone GW et al, N Engl J Med 2007

29 Sirolimus Eluting Stents 29 Source: Stone GW et al, N Engl J Med 2007

30 Stent thrombosis: Analysis of 14 Trials Comparing SES with BMS 4958 patients, follow-up: months Risk of stent thrombosis was at least as great as that seen with BMS Source: N Engl J Med 2007;356: Kaplan Meier Curves for Stent Thrombosis in the Pooled Population According to Stent Type and the Duration 30 of Dual Antiplatelet Therapy

31 Long-term outcome with DES vs BMS in Sweden - SCAAR study Drug-eluting stents were associated with an increased rate of death, as compared with bare-metal stents. This trend appeared after 6 months 31 Source: Lagerqvist et al. N Engl J Med 2007;356:

32 Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: Occurrence and frequency of stent thrombosis overtime 0.6% per year Independent predictors of overall ST: Diabetes (hazard ratio: 2.03, 95% CI: ) ACS (hazard ratio :2.28, 95% CI : ) Source: Daemen et al. Lancet 2007;369:

33 Incidence, predictors, and outcome of drug-eluting stent thrombosis (ST) in real-world clinical practice Multicenter Spanish Registry ESTROFA: 23,500 patients, 3 years follow-up Cumulative Incidence of ST 33 Source: J Am Coll Cardiol 2008;51:986 90

34 Incidence, predictors, and outcome of drug-eluting stent thrombosis (ST) in real-world clinical practice Multicenter Spanish Registry ESTROFA: 23,500 patients, 3 years follow-up The cumulative incidence of angiographically documented stent thrombosis was 2% at 3 years. No differences were found between paclitaxel-eluting and sirolimus-eluting stents. The profiles of patients with early and late thrombosis were different. The short-term prognosis is poor, especially when the restoration of normal flow has failed. 34 Source: J Am Coll Cardiol 2008;51:986 90

35 The Recent Inconvenient Truth from Registries, Real Life Data and Long Term Follow-up VERY CONCERNING 35

36 Mortality in RCTs comparing DES vs BMS Conclusion Drug-eluting stents for the treatment of coronary artery disease do not reduce total mortality when compared with bare metal stents. Preliminary evidence suggests that sirolimus- but not paclitaxel-eluting stents may lead to increased non-cardiac mortality. Long-term follow-up and assessment of cause-specific deaths in patients receiving drug-eluting stents is mandatory to determine the long-term safety of these devices. 36 Source: Nordmann AJ et al, Eur Heart J Oct 2006

37 Mortality in RCTs comparing DES vs BMS 37 Source: Nordmann AJ et al, Eur Heart J Oct 2006

38 Mortality in RCTs comparing DES vs BMS 38 Source: Nordmann AJ et al, Eur Heart J Oct 2006

39 Mortality in RCTs comparing DES vs BMS 39 Source: Nordmann AJ et al, Eur Heart J Oct 2006

40 Outcomes associated with drug-eluting and baremetal stents: a collaborative network meta analysis 38 trials, pts Cumulative incidence of overall death & cardiac death Source: Stettler et al. Lancet 2007; 370:

41 Outcomes associated with drug-eluting and baremetal stents: a collaborative network meta analysis Cumulative incidence of MI & death or MI Source: Stettler et al. Lancet 2007; 370:

42 Outcomes associated with drug-eluting and baremetal stents: a collaborative network meta analysis Cumulative incidence of Definite SR & TLR Source: Stettler et al. Lancet 2007; 370:

43 Outcomes associated with drug-eluting and baremetal stents: a collaborative network meta analysis Stratified analysis according to presence or absence of diabetes mellitus Cumulative incidence of death or MI Source: Stettler et al. Lancet 2007; 370:

44 Effectiveness and Safety of Drug-Eluting Stents in Ontario Event-free survival Source: N Engl J Med Oct 4;357(14):

45 Effectiveness and Safety of Drug-Eluting Stents in Ontario DES are more effective than BMS in reducing the need for target-vessel revascularization in patients at highest risk for restenosis after PCI but offer minimal benefit to patients at lower risk. There is a small absolute difference in mortality in favor of DES that should be confirmed or refuted through large, randomized clinical trials with long-term follow-up. Source: N Engl J Med Oct 4;357(14):

46 Long-Term Safety and Efficacy of DES: Two-Year Results of the REAL Multicenter Registry REAL (REgistro AngiopLastiche dell Emilia Romagna) Multicenter Registry 10,629 patients TVR Death and acute MI MACE Propensity score adjusted cumulative incidence The beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile 46 Source: Circulation. 2007;115:

47 Comparative Clinical Outcomes of Paclitaxel- and Sirolimus-Eluting Stents STENT Group PES=4671 pts - SES=4555 pts PES and SES were associated with low and indistinguishable overall MACE rates, including similar rates of ST, at 9 months follow-up Source: J Am Coll Cardiol 2007;50:

48 DES OFF-LABEL USE 48

49 DES: Off-label use More complex and unapproved indications Very small vessels and very long lesions Chronic total occlusions Bifurcations Left main disease In-stent restenosis Multivessel disease Saphenous vein grafts Acute myocardial infarction 49

50 Clinical Outcomes and Stent Thrombosis Following Off-Label Use of Drug-Eluting Stents Souce: Win et al. JAMA 2007;297:

51 Clinical Outcomes and Stent Thrombosis Following Off-Label Use of Drug-Eluting Stents TLR Source: Behoar et al. JAMA 2007;297:

52 DES: Off label use - conclusions Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drugeluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed. Souce: Win et al. JAMA 2007;297:

53 Potential Mechanisms for Stent Thrombosis 53

54 Hypothetic Major Mechanisms? Delayed Endothelialisation Late Stent Thrombosis Abnormal Blood Flow Increased Blood Thrombogenicity 54

55 Percent Percentage Endothelialization Percent Incomplete Strut Endothelialization is Usual in Patients Sirolimus-eluting stent Incomplete coverage Complete coverage Grade 0 Grade 1 Grade 2 Grade 3 75 Bare metal stent Angioscopy at 8 months post SES implantation BMS DES >40 Duration in months Virmani autopsy data 55 Source: Kotani J et al. JACC. 2006,47:2108 Source: Joner M et al. JACC. 2006;48:193.

56 Cypher A B 65 yo male with h/o Cypher stent placement to the prox LAD and BXVelocity to the distal LAD 15-months prior to non-cardiac death C No endothelialization Fibrin BxVelocity D E F Strut Fibrin Neointima Source: Joner M & Finn AV. J Am Coll Cardiol Jul 4;48(1):

57 Delayed Endothelialization Overlapping SES vs PES BMS SES BMS PES Overlap Overlap Conclusions: BMS showed far greater endothelialization than DES Lack of coverage highlighted in areas of overlap Less surface coverage by endothelial cells in PES than SES 57 Source: Finn AV. Circulation 2005

58 Hypothetic Major Mechanisms? Delayed Endothelialisation Late Stent Thrombosis Abnormal Blood Flow Increased Blood Thrombogenicity 58

59 Why an abnormal flow? Suboptimal stent deployment Incomplete stent apposition Struts fracture Off label use (bifurcation,crushing, multiple overlapping stents ) Drug related endothelial dysfunction (in-stent and out of stent) 59

60 Late Incomplete Mal-Apposition Drug-Eluting Stent Group 60

61 Hypothetic Major Mechanisms? Delayed Endothelialisation Late Stent Thrombosis Abnormal Blood Flow Increased Blood Thrombogenicity 61

62 Univariate Predictors of Cumulative DES Thrombosis Premature antiplatelet therapy discontinuation Prior brachytherapy Renal failure Bifurcation with 2 stents Bifurcation lesion Unprotected left main artery Diabetes 8.7% 6.2% 3.9% 3.6% 3.3% 2.5% 29.0% 2,272 SES 2,223 PES Incidence stent thrombosis Source: Iakovou et al. JAMA

63 63 Source: Iakovou et al. JAMA 2005

64 Predictors of DES Thrombosis Premature or delayed / late antiplatelet therapy discontinuation (after patient or physician decision) is THE major predictor for (late) stent thrombosis : Jeremias et al, Circulation 2004 Iakovou et al, JAMA 2005 Ong et al, JACC 2005 Kuchulakanti et al, Circulation 2006 Park et al, Am J Cardiol

65 Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation 65 Source: Eisenstein et al. JAMA 2007;297:

66 Risk Factors for Stent Thrombosis After Implantation of SES in Diabetic and Nondiabetic Patients The EVASTENT Matched-Cohort Registry Event rate at one-year follow-up 66

67 Stent Thrombosis: a Complex Mechanism TECHNICAL IMPROVEMENT PATIENT/LESION TRIAGE STENT THROMBOGENICITY -Material -Design -Surface coating -Adjunctive thérapy (drug,radiation) BIO COMPAT PATIENT/LESION FACTORS -Vessel size/lesion lenght -Acute coronary syndrome -Plaque characteristics/complexity -Local platelet/ coagulation activity PROCEDURE RELATED FACTORS -Morphometric factors (underexpansion,assymetry) -Morphologic factors (dissection, Uncomplete apposition,thrombus) -Mechanical vessel injury -Antithrombotic therapy Patient Compliance!! INFORMATION PROCEDURAL OPTIMIZATION 67

68 LATE STENT THROMBOSIS Is a True REALITY! 68

69 Summary When there is uncertainty or doubt we must adopt a precautionary attitude A precautionary attitude must be considered the foundation in an ethic of precaution based upon the principle of responsibility 69

70 DES: Baseline Knowledge 1. In highly selected patients, randomised clinical trials (RCTs) have proven a significant and consistent reduction in the need for target vessel revascularisation (TVR) in DES when compared to BMS 2. RCTs conducted with the aim of analysing the efficacy and safety of DES as compared to BMS, do not have the statistical power to demonstrate an equivalence (or non-inferiority) for isolated events such as death, MI or late stent thrombosis 3. Meta-analysis did not reveal a statistically significant excess of overall risk of death, MI & stent thrombosis with DES 4. Meta-analysis revealed a modestly increased risk of late stent thrombosis (> 1 years); the overall evidence is approximately 1.0 to 2.6 per 1000 pts/yr 70

71 DES: Baseline Knowledge 5. RCTs include only highly selected groups of patients, reflecting ±1/3 of patients requiring revascularisation for CAD in daily practice 6. Several reports imply that the late (>1yr) stent thrombosis rate of DES may be higher in the «real world» than in RCTs 7. The rate of such events is very low (something between approximately 0.75 to 3.5%/year according to the group of patients treated) and imply multiple related factors 8. LAST may occur in patients with dual antiplatelet treatment and there is a strong association with mortality and morbidity 71

72 Dual antiplatelet treatment after DES Key Points To Consider Premature antiplatelet regimen discontinuation is highly associated with stent thrombosis in DES patients. There is an uncertain advantage for long-term antiplatelet treatment due to a potential increased risk of bleeding with extended treatment. Current guidelines recommend 12 months of dual antiplatelet therapy after DES treatment. Very late DES thrombosis may occur in patients with antiplatelet treatment. 72

73 When do I prefer Bare Metal Stents and when do I prefer Drug Eluting Stents? Practical Recommendations 73

74 Benefit / Risk Profile of DES vs BMS Risk Benefit Stent thrombosis Reduced restenosis MI, Death, TLR How do these 2 risks (thrombosis vs. restenosis) balance out? 74 TLR = target lesion revascularization.

75 Reasons for choosing Short lesions Large reference diameter Second lesion in 2VD Difficult anatomy (tortuosity, calcification) Planned short-term interruption in antiplatelet medication most AMI BMS Long lesions DES Small reference diameter In-stent restenosis Chronic total occlusion Good compliance anticipated with ASA + thienopyridine Adequate reimbursement Lack of reimbursement 75

76 Recommendations for the use of DES Before selecting the revascularization technique : investigate the potential problems! Problem with prolonged A + C? Risk of surgery in coming months? Suspected compliance issue (+++) Allergy to ASA or Clopidogrel? YES Consider BMS or CABG for complex lesions? NO non diabetic, 3.5 mm vessel, < 15mm lesion YES Consider BMS? NO ASA+ clopidogrel DES Clearly Inform patient before PCI

77 Unplanned Surgery after DES Can surgery be delayed 6-12 months? YES C + A Clearly inform the patient NO! Convince the surgical team to work with C+A? YES C + A Clearly inform the patient: bleeding risk! NO! Stop A+C as short a time as possible (5 days) Replacement option? 77 Clearly inform the patient about LAST

78 DES COST-EFFECTIVENESS 78

79 Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a realworld setting Randomised Basel Stent Kosten Effektivitäts Trial (BASKET) In a real-world setting, use of DES in all patients is less cost effective than in studies with selected patients. Use of these stents could be restricted to patients in high-risk groups. Source: Kaiser et al. Lancet 2005;366:

80 Cost-effectiveness of the unrestricted use of sirolimus-eluting stents vs. bare metal stents at 1 and 2-year follow-up The use of SES, while significantly beneficial in reducing the need for repeat revascularization, was more expensive and not cost-effective in the RESEARCH registry at either 1 or 2-years when compared with BMS. 80 Source: Ong et al. Eur Heart J 2006;27:

81 DES studies SPIRIT IV Trial Compare Trial ISAR-TEST 4 Trial SORT OUT 4 Everolimus vs Sirolimus 81

82 82

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91 91

92 Cases Review 92

93 Case 1 K. D. Age : 24 years Gender : male Risk factors : - hypertension - smoker - positive family history 93

94 Location, approach, type of stent p LAD Approach Stent to p RCA Balloon post dilatation Balloon post dilatation 99%+TIMI flow=3 trans radial DES 3.5/23mm x 16atm 4.0/9mm x 13atm 4.0/9mm x 17atm 94

95 Right coronary artery 95

96 Left coronary artery 96

97 p LAD : 99% stenosis 97

98 DES 3.5/23mm x 16atm 98

99 Result 99

100 NC Balloon post dilatation 4.0/9mm x 10atm 100

101 Result 101

102 NC Balloon post dilatation 4.0/9mm x 13atm 102

103 Final result 103

104 Final result 104

105 Case 2 M. R. Age : 57 years Gender : male Risk factors : - hypertension - smoker - positive family history 105

106 Location, approach, type of stent m RCA d RCA r PDA m LAD d LCx Approach Stent to m RCA Stent to d RCA POBA to m RCA 90%+TIMI flow=3 95%+TIMI flow=3 95%+TIMI flow=3 intermediate 90%+TIMI flow=3 trans radial DES 3.0/23mm x 12atm BMS 3.0/17mm x 10atm Balloon 2.0/20mm x 8atm 106

107 Right coronary artery 107

108 Right coronary artery 108

109 Right coronary artery 109

110 Left coronary artery 110

111 Left coronary artery 111

112 Balloon pre-dilatation 3.0/18mm x 5atm 112

113 Result 113

114 BMS 3.0/17mm x 10atm 114

115 Result 115

116 DES 3.0/23mm x 12atm 116

117 NC Balloon post-dilatation 3.5/9mm x 14atm 117

118 Final result 118

119 Case 3 K. A. Age : 65 years Gender : female Risk factors : - hypertension - positive family history 119

120 Location, approach, type of stent m LAD p LCx Approach Balloon pre dilatation Stent 99%+TIMI flow=3 intermediate trans radial 2.0/20mm x 10atm BMS 2.75/18mm x 14atm 120

121 Right coronary artery 121

122 Left coronary artery 122

123 m LAD : 99% stenosis 123

124 Balloon pre dilatation 2.0/20mm x 10atm 124

125 Result 125

126 BMS 2.75/18mm x 14atm 126

127 Final result 127

128 Four months later 128

129 Location, approach, type of stent m LAD p LCx Approach Balloon pre dilatation Balloon pre dilatation Stent Balloon post dilatation 99%+instent intermediate trans radial 3.0/15mm x 8 atm 3.0/20mm x 10atm DES 3.0/38mm x 12atm NC 3.0/6mm x 15atm 129

130 Right coronary artery 130

131 Left coronary artery 131

132 m LAD: 99% instent restenosis 132

133 Balloon pre dilatation 3.0/15mm x 8atm 133

134 Result post dilatation (dissection plad - guiding catheter induced) 134

135 Balloon pre dilatation 3.0/20mm x 10atm 135

136 Result 136

137 Result 137

138 DES 3.0/38mm positioning 138

139 DES 3.0/38mm positioning 139

140 DES 3.0/38mm x 12atm deployment 140

141 Result 141

142 Result 142

143 NC Balloon post dilatation 3.0/6mm x 15atm 143

144 Final result 144

145 Case 4 S. K. Age : 56 years Gender : male Risk factors : - hypertension - hiperlipidemia - smoker 145

146 Location, approach, type of stent p RCA m RCA p LAD Approach Stent to p RCA Stent to m RCA 90%+TIMI flow=3 99%+TIMI flow=3 100%+TIMI flow=0 trans radial DES 3.0/24mm x 16atm BMS 3.5/15mm x 13atm 146

147 Left coronary artery (plad: 100% - CTO) 147

148 Left coronary artery 148

149 Right coronary artery 149

150 Right coronary artery 150

151 BMS 3.5/15mm x 13atm 151

152 Result 152

153 DES 3.0/24mm x 16atm 153

154 Final result 154

155 Four years later 155

156 Location, approach, type of stent p LAD Approach Balloon dilatation dlad Balloon dilatation dlad Stent to p LAD Stent to m LAD 100%+TIMI flow=0 trans radial 1.5/20mm x 8atm 2.5/20mm x 10atm DES 3.0/28mm x 20atm DES 3.0/28mm x 10atm 156

157 Right coronary artery 157

158 Right coronary artery 158

159 Left coronary artery 159

160 p LAD : 100% (CTO) 160

161 Guiding cath EBU 4.0/5 Fr; Hydrophilic guide wire

162 Balloon pre dilatation 1.5/20mm x 10atm 162

163 Balloon pre dilatation 2.5/20mm x 10atm 163

164 Result 164

165 DES 3.0/28mm x 20atm 165

166 DES 3.0/28mm x 20atm 166

167 Result 167

168 Balloon pre dilatation 2.5/20mm x 8atm 168

169 Result 169

170 DES 3.0/28mm x 10atm 170

171 Final result 171

172 Quick Self Assessment DES updates 172

173 Acute stent thrombosis occurs after: a) < 24 hours b) 24 hours - 30 days c) 1-6 months d) > 6 months 173

174 Acute stent thrombosis occurs after: a) < 24 hours b) 24 hours - 30 days c) 1-6 months d) > 6 months 174

175 Hypothetic major mechanisms of late stent thrombosis are (all true EXCEPT): a) Delayed endothelization b) Abnormal blood flow c) Increased thrombogenicity d) High serum creatinin level 175

176 Hypothetic major mechanisms of late stent thrombosis are (all true EXCEPT): a) Delayed endothelization b) Abnormal blood flow c) Increased thrombogenicity d) High serum creatinin level 176

177 Major predictor for late stent thrombosis is: a) Bare metal stent implantation b) Early dual antiplatelet discontinuation c) Male gender d) Second generation drug eluting stent implantation 177

178 Major predictor for late stent thrombosis is: a) Bare metal stent implantation b) Early dual antiplatelet discontinuation c) Male gender d) Second generation drug eluting stent implantation 178

179 Off label use means: a) Approved indications b) Operator s personal opinion c) Unapproved indications d) Patient s unsigned written consent 179

180 Off label use means: a) Approved indications b) Operator s personal opinion c) Unapproved indications d) Patient s unsigned written consent 180

181 Which stents are randomized in COMPARE all comers trial: a) Xience V vs Taxus Liberte b) Taxus Liberte vs Cypher Select c) Endeavor Resolute vs Taxus Liberte d) Xience V vs Endeavor Resolute 181

182 Which stents are randomized in COMPARE all comers trial: a) Xience V vs Taxus Liberte b) Taxus Liberte vs Cypher Select c) Endeavor Resolute vs Taxus Liberte d) Xience V vs Endeavor Resolute 182

183 ABSORB first in man study for bioabsorbable DES evaluate: a) BVS - Sirolimus b) REVA - Paclitaxel c) BVS - Everolimus d) IDEAL - Sirolimus 183

184 ABSORB first in man study for bioabsorbable DES evaluate: a) BVS - Sirolimus b) REVA - Paclitaxel c) BVS - Everolimus (Bioresorbable vascular scaffold) d) IDEAL - Sirolimus 184

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